A 90-day repeated-dose oral toxicity study on Flos lonicerae extract in Fischer 344/N rats
2008
Han, Zhong-Ze (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Zhang, H.S. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Kang, S.C. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Gil, K.H. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Kong, K.H. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Kim, D.H. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Ahn, T.H. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Bae, J.S. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Go, H.K. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Han, M.K. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Kim, H.S. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Heo, H.S. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Park, E.M. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Song, S.W. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Kim, K.H. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Park, C.K. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea) | Lee, H.K. (Preclinical Research Center, ChemOn, Yongin, Republic of Korea), E-mail: leehk@chemon.co.kr
This study was performed to evaluate repeated-dose oral toxicities of Flos lonicerae extract in Fischer 344/n rats. Flos lonicerae was administered orally to rats at dose levels of 0, 37, 111, 333, 1,000 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Flos lonicerae extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program and The Standards of Toxicity Study for Medicinal Products. In the present study, there were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Flos lonicerae extract. These results suggest that the oral no observed adverse-effect level of the test item, Flos lonicerae extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.
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